Chronic Nonspecific Low Back PainNCT04534179
Vacuum Myofascial Therapy Device and Physical Activity for the Treatment of Chronic Non-specific Low Back Pain. A Single Blind Randomized Clinical Trial
A study testing Vacuum myofascial therapy and physical activity program. and Physical activity program. in people with Chronic Nonspecific Low Back Pain, run by University of Cadiz at 1 site in Spain.
Trial summary
The term non-specific low back pain refers to the painful symptoms located in the lumbar region, which is delimited between the lower margin of the ribs and the lower limit of the buttocks Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Chronic Nonspecific Low Back Pain
- What is being tested?
- Vacuum myofascial therapy and physical activity program. and Physical activity program.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed of Chronic Nonspecific Low Back Pain that do not improve with conventional physiotherapy or pharmacological therapy protocols.
- Subjects who are in an active state of pain
Who cannot join
- Individuals who have received surgery intervention in the spine
- Individuals have received the proposed treatment in one month´s period previously.
- Individuals who suffering from fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema.
- Pregnant women can not receive this treatment intervention.
Trial locations and contacts
1 site in 1 country.
About this study
The term non-specific low back pain refers to the painful symptoms located in the lumbar region, which is delimited between the lower margin of the ribs and the lower limit of the buttocks
Read the detailed description
This study aimed to investigate the efficacy of a vacuum myofascial therapy device (VT) for improving pressure pain thresholds (PPTs), functionality, range of motion (ROM), low back pain-related disability, pain, and quality of life in patients with non-specific low back pain. Methods: A randomized controlled trial in which participants with non-specific low back pain (NP) were randomly assigned to either an experimental (VT) or a comparison physical therapy program (PTP) group.
- Conditions
- Chronic Nonspecific Low Back Pain
- Being tested
- Vacuum myofascial therapy and physical activity program., Physical activity program.
- Keywords
- negative pressure, vacuum, low back pain, physical therapy modalities, cupping
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum myofascial therapy and physical activity program.Procedure or surgery
This group will treated five times with the analgesic program of physium therapy. Each maneuver was performed once per session by slow and progressive. The whole procedure lasted no more than 30 minutes.
Then they carried out the physical activity program
Physical activity program.Other
Active Comparator: Physical activity The exercise protocol would last 5 weeks, performing 3 exercise sessions per week, with an effective work time of 20 minutes per session. The exercises would be directly focused on activating the core stabilizing muscles.
| Study group | Role | What they receive |
|---|---|---|
| Vacuum myofascial therapy and physical activity | Experimental | The protocol would last 5 weeks, group received fifteen 30-minute sessions of vacuum myofascial therapy and fifteen sessions physical activity program similar to the control group per week. Receives: Procedure: Vacuum myofascial therapy and physical activity program. |
| Physical activity Program | Active comparator | The exercise protocol would last 5 weeks, performing 3 exercise sessions per week, with an effective work time of 30 minutes per session. The exercises would be directly focused on activating the core stabilizing muscles. Receives: Other: Physical activity program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intensity of pain: 10-point Numerical Pain Rating Scale
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area. The minimal clinically important difference (MCID) for the NPRS in patients with shoulder pain was 1.1 points (Mintken, Glynn, and Cleland 2009).
Measured: Baseline
Secondary outcomes (6)
The intensity of pain: 10-point Numerical Pain Rating Scale
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of lumbar pain, and the worst and lowest level of pain experienced in the preceding week in the lumbar area.
Measured: Immediately after the intervention , four and twelve weeks
Active range of motion of the lumbar spine
Measured by a two branches goniometer
Measured: Baseline , immediately after treatment, four and twelve weeks
Pressure pain thresholds in trigger points
Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline, Pain TestTM, Wagner Instruments). The clinimetric properties of this instrument have been evaluated previously. The PPT will the point at which pressure elicited pain and will presented as kilograms per square centimeter. All measurements will be conducted by the same well-trained physician.
Measured: Baseline, immediately rafter treatment, four and twelve weeks
Questionnaire SF 12
The multidimensional health related quality of life
Measured: Baseline, immediately after treatment, four and twelve weeks
OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE
The Oswestry Low Back Pain Disability Scale is a self-administered questionnaire, specific for low back pain, that measures limitations in daily activities.
Measured: Baseline, immediately after treatment, four and twelve weeks
Roland Morris Disability Questionnaire
Roland Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities
Measured: Baseline, immediately after treatment, four and twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Sep 2020
- Primary completion15 Dec 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Chronic Nonspecific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A specialist physician will be diagnosed chronic nonspecific low back pain
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Rodriguez Huguet, University of Cadiz
- Investigators
- Manuel Manuel, Principal investigator, University of Cádiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534179
- Sponsor's protocol ID
- Physium and physical therapy
- Status last verified
- Feb 2022
- First submitted
- 17 Aug 2020
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
PubMed 16550448Calatayud J, Escriche-Escuder A, Cruz-Montecinos C, Andersen LL, Perez-Alenda S, Aiguade R, Casana J. Tolerability and Muscle Activity of Core Muscle Exercises in Chronic Low-back Pain. Int J Environ Res Public Health. 2019 Sep 20;16(19):3509. doi: 10.3390/ijerph16193509.
PubMed 31547140Alsufiany MB, Lohman EB, Daher NS, Gang GR, Shallan AI, Jaber HM. Non-specific chronic low back pain and physical activity: A comparison of postural control and hip muscle isometric strength: A cross-sectional study. Medicine (Baltimore). 2020 Jan;99(5):e18544. doi: 10.1097/MD.0000000000018544.
PubMed 32000363Vadala G, Russo F, De Salvatore S, Cortina G, Albo E, Papalia R, Denaro V. Physical Activity for the Treatment of Chronic Low Back Pain in Elderly Patients: A Systematic Review. J Clin Med. 2020 Apr 5;9(4):1023. doi: 10.3390/jcm9041023.
PubMed 32260488Hayden JA, Wilson MN, Stewart S, Cartwright JL, Smith AO, Riley RD, van Tulder M, Bendix T, Cecchi F, Costa LOP, Dufour N, Ferreira ML, Foster NE, Gudavalli MR, Hartvigsen J, Helmhout P, Kool J, Koumantakis GA, Kovacs FM, Kuukkanen T, Long A, Macedo LG, Machado LAC, Maher CG, Mehling W, Morone G, Peterson T, Rasmussen-Barr E, Ryan CG, Sjogren T, Smeets R, Staal JB, Unsgaard-Tondel M, Wajswelner H, Yeung EW; Chronic Low Back Pain IPD Meta-Analysis Group. Exercise treatment effect modifiers in persistent low back pain: an individual participant data meta-analysis of 3514 participants from 27 randomised controlled trials. Br J Sports Med. 2020 Nov;54(21):1277-1278. doi: 10.1136/bjsports-2019-101205. Epub 2019 Nov 28.
PubMed 31780447Hong S, Shin D. Relationship between pain intensity, disability, exercise time and computer usage time and depression in office workers with non-specific chronic low back pain. Med Hypotheses. 2020 Apr;137:109562. doi: 10.1016/j.mehy.2020.109562. Epub 2020 Jan 9.
PubMed 31945657Shamsi M, Mirzaei M, HamediRad M. Comparison of muscle activation imbalance following core stability or general exercises in nonspecific low back pain: a quasi-randomized controlled trial. BMC Sports Sci Med Rehabil. 2020 Apr 15;12:24. doi: 10.1186/s13102-020-00173-0. eCollection 2020.
PubMed 32313659Cruz-Diaz D, Romeu M, Velasco-Gonzalez C, Martinez-Amat A, Hita-Contreras F. The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2018 Sep;32(9):1249-1257. doi: 10.1177/0269215518768393. Epub 2018 Apr 13.
PubMed 29651872Kim M, Kim M, Oh S, Yoon B. The Effectiveness of Hollowing and Bracing Strategies With Lumbar Stabilization Exercise in Older Adult Women With Nonspecific Low Back Pain: A Quasi-Experimental Study on a Community-based Rehabilitation. J Manipulative Physiol Ther. 2018 Jan;41(1):1-9. doi: 10.1016/j.jmpt.2017.06.012. Epub 2017 Dec 16.
PubMed 29254626Sipaviciene S, Kliziene I. Effect of different exercise programs on non-specific chronic low back pain and disability in people who perform sedentary work. Clin Biomech (Bristol). 2020 Mar;73:17-27. doi: 10.1016/j.clinbiomech.2019.12.028. Epub 2020 Jan 3.
PubMed 31923778Taulaniemi A, Kankaanpaa M, Tokola K, Parkkari J, Suni JH. Neuromuscular exercise reduces low back pain intensity and improves physical functioning in nursing duties among female healthcare workers; secondary analysis of a randomised controlled trial. BMC Musculoskelet Disord. 2019 Jul 13;20(1):328. doi: 10.1186/s12891-019-2678-x.
PubMed 31301741Ibrahim AA, Akindele MO, Ganiyu SO, Bello B. Effects of motor control exercise and patient education program in the management of chronic low back pain among community-dwelling adults in rural Nigeria: a study protocol for a randomized clinical trial. Integr Med Res. 2019 Jun;8(2):71-81. doi: 10.1016/j.imr.2019.02.001. Epub 2019 Feb 21.
PubMed 31080731Teychenne M, Lamb KE, Main L, Miller C, Hahne A, Ford J, Rosenbaum S, Belavy D. General strength and conditioning versus motor control with manual therapy for improving depressive symptoms in chronic low back pain: A randomised feasibility trial. PLoS One. 2019 Aug 1;14(8):e0220442. doi: 10.1371/journal.pone.0220442. eCollection 2019.
PubMed 31369613Ozsoy G, Ilcin N, Ozsoy I, Gurpinar B, Buyukturan O, Buyukturan B, Kararti C, Sas S. The Effects Of Myofascial Release Technique Combined With Core Stabilization Exercise In Elderly With Non-Specific Low Back Pain: A Randomized Controlled, Single-Blind Study. Clin Interv Aging. 2019 Oct 9;14:1729-1740. doi: 10.2147/CIA.S223905. eCollection 2019.
PubMed 31631992Kim S, Lee SH, Kim MR, Kim EJ, Hwang DS, Lee J, Shin JS, Ha IH, Lee YJ. Is cupping therapy effective in patients with neck pain? A systematic review and meta-analysis. BMJ Open. 2018 Nov 5;8(11):e021070. doi: 10.1136/bmjopen-2017-021070.
PubMed 30397006
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum Myofascial Therapy Device and Physical Activity for the Treatment of Chronic Non-specific Low Back Pain. A Single Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04534179
- Acronym / sponsor ID
- Physium and physical therapy
- Conditions
- Chronic Nonspecific Low Back Pain
- Keywords
- negative pressure, vacuum, low back pain, physical therapy modalities, cupping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The term non-specific low back pain refers to the painful symptoms located in the lumbar region, which is delimited between the lower margin of the ribs and the lower limit of the buttocks
Detailed description
This study aimed to investigate the efficacy of a vacuum myofascial therapy device (VT) for improving pressure pain thresholds (PPTs), functionality, range of motion (ROM), low back pain-related disability, pain, and quality of life in patients with non-specific low back pain. Methods: A randomized controlled trial in which participants with non-specific low back pain (NP) were randomly assigned to either an experimental (VT) or a comparison physical therapy program (PTP) group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A specialist physician will be diagnosed chronic nonspecific low back pain
| Arm | Type | Receives |
|---|---|---|
| Vacuum myofascial therapy and physical activity | Experimental | Procedure: Vacuum myofascial therapy and physical activity program.The protocol would last 5 weeks, group received fifteen 30-minute sessions of vacuum myofascial therapy and fifteen sessions physical activity program similar to the control group per week. |
| Physical activity Program | Active comparator | Other: Physical activity program.The exercise protocol would last 5 weeks, performing 3 exercise sessions per week, with an effective work time of 30 minutes per session. The exercises would be directly focused on activating the core stabilizing muscles. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients diagnosed of Chronic Nonspecific Low Back Pain that do not improve with conventional physiotherapy or pharmacological therapy protocols.
- Subjects who are in an active state of pain
Key exclusion criteria (4 listed)
- Individuals who have received surgery intervention in the spine
- Individuals have received the proposed treatment in one month´s period previously.
- Individuals who suffering from fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema.
- Pregnant women can not receive this treatment intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum myofascial therapy and physical activity program.This group will treated five times with the analgesic program of physium therapy. Each maneuver was performed once per session by slow and progressive. The whole procedure lasted no more than 30 minutes. Then they carried out the physical activity program | Procedure or surgery | Vacuum myofascial therapy and physical activity |
| Physical activity program.Active Comparator: Physical activity The exercise protocol would last 5 weeks, performing 3 exercise sessions per week, with an effective work time of 20 minutes per session. The exercises would be directly focused on activating the core stabilizing muscles. | Other | Physical activity Program |
Primary outcome
The intensity of pain: 10-point Numerical Pain Rating Scale
Time frame: Baseline
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area. The minimal clinically important difference (MCID) for the NPRS in patients with shoulder pain was 1.1 points (Mintken, Glynn, and Cleland 2009).
6 secondary outcomes
The intensity of pain: 10-point Numerical Pain Rating Scale
Time frame: Immediately after the intervention , four and twelve weeks
Active range of motion of the lumbar spine
Time frame: Baseline , immediately after treatment, four and twelve weeks
Pressure pain thresholds in trigger points
Time frame: Baseline, immediately rafter treatment, four and twelve weeks
Questionnaire SF 12
Time frame: Baseline, immediately after treatment, four and twelve weeks
OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE
Time frame: Baseline, immediately after treatment, four and twelve weeks
Roland Morris Disability Questionnaire
Time frame: Baseline, immediately after treatment, four and twelve weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 16550448Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
- Background: PubMed 31547140Calatayud J, Escriche-Escuder A, Cruz-Montecinos C, Andersen LL, Perez-Alenda S, Aiguade R, Casana J. Tolerability and Muscle Activity of Core Muscle Exercises in Chronic Low-back Pain. Int J Environ Res Public Health. 2019 Sep 20;16(19):3509. doi: 10.3390/ijerph16193509.
- Background: PubMed 32000363Alsufiany MB, Lohman EB, Daher NS, Gang GR, Shallan AI, Jaber HM. Non-specific chronic low back pain and physical activity: A comparison of postural control and hip muscle isometric strength: A cross-sectional study. Medicine (Baltimore). 2020 Jan;99(5):e18544. doi: 10.1097/MD.0000000000018544.
- Background: PubMed 32260488Vadala G, Russo F, De Salvatore S, Cortina G, Albo E, Papalia R, Denaro V. Physical Activity for the Treatment of Chronic Low Back Pain in Elderly Patients: A Systematic Review. J Clin Med. 2020 Apr 5;9(4):1023. doi: 10.3390/jcm9041023.
- Background: PubMed 31780447Hayden JA, Wilson MN, Stewart S, Cartwright JL, Smith AO, Riley RD, van Tulder M, Bendix T, Cecchi F, Costa LOP, Dufour N, Ferreira ML, Foster NE, Gudavalli MR, Hartvigsen J, Helmhout P, Kool J, Koumantakis GA, Kovacs FM, Kuukkanen T, Long A, Macedo LG, Machado LAC, Maher CG, Mehling W, Morone G, Peterson T, Rasmussen-Barr E, Ryan CG, Sjogren T, Smeets R, Staal JB, Unsgaard-Tondel M, Wajswelner H, Yeung EW; Chronic Low Back Pain IPD Meta-Analysis Group. Exercise treatment effect modifiers in persistent low back pain: an individual participant data meta-analysis of 3514 participants from 27 randomised controlled trials. Br J Sports Med. 2020 Nov;54(21):1277-1278. doi: 10.1136/bjsports-2019-101205. Epub 2019 Nov 28.
- Background: PubMed 31945657Hong S, Shin D. Relationship between pain intensity, disability, exercise time and computer usage time and depression in office workers with non-specific chronic low back pain. Med Hypotheses. 2020 Apr;137:109562. doi: 10.1016/j.mehy.2020.109562. Epub 2020 Jan 9.
- Background: PubMed 32313659Shamsi M, Mirzaei M, HamediRad M. Comparison of muscle activation imbalance following core stability or general exercises in nonspecific low back pain: a quasi-randomized controlled trial. BMC Sports Sci Med Rehabil. 2020 Apr 15;12:24. doi: 10.1186/s13102-020-00173-0. eCollection 2020.
- Background: PubMed 29651872Cruz-Diaz D, Romeu M, Velasco-Gonzalez C, Martinez-Amat A, Hita-Contreras F. The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2018 Sep;32(9):1249-1257. doi: 10.1177/0269215518768393. Epub 2018 Apr 13.
- Background: PubMed 29254626Kim M, Kim M, Oh S, Yoon B. The Effectiveness of Hollowing and Bracing Strategies With Lumbar Stabilization Exercise in Older Adult Women With Nonspecific Low Back Pain: A Quasi-Experimental Study on a Community-based Rehabilitation. J Manipulative Physiol Ther. 2018 Jan;41(1):1-9. doi: 10.1016/j.jmpt.2017.06.012. Epub 2017 Dec 16.
- Background: PubMed 31923778Sipaviciene S, Kliziene I. Effect of different exercise programs on non-specific chronic low back pain and disability in people who perform sedentary work. Clin Biomech (Bristol). 2020 Mar;73:17-27. doi: 10.1016/j.clinbiomech.2019.12.028. Epub 2020 Jan 3.
- Background: PubMed 31301741Taulaniemi A, Kankaanpaa M, Tokola K, Parkkari J, Suni JH. Neuromuscular exercise reduces low back pain intensity and improves physical functioning in nursing duties among female healthcare workers; secondary analysis of a randomised controlled trial. BMC Musculoskelet Disord. 2019 Jul 13;20(1):328. doi: 10.1186/s12891-019-2678-x.
- Background: PubMed 31080731Ibrahim AA, Akindele MO, Ganiyu SO, Bello B. Effects of motor control exercise and patient education program in the management of chronic low back pain among community-dwelling adults in rural Nigeria: a study protocol for a randomized clinical trial. Integr Med Res. 2019 Jun;8(2):71-81. doi: 10.1016/j.imr.2019.02.001. Epub 2019 Feb 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Manuel principal investigator
University of Cádiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum myofascial therapy and physical activity program. and Physical activity program. in people with Chronic Nonspecific Low Back Pain, run by University of Cadiz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The intensity of pain: 10-point Numerical Pain Rating Scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534179, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.